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Trial registered on ANZCTR


Registration number
ACTRN12609000496213
Ethics application status
Approved
Date submitted
7/05/2009
Date registered
22/06/2009
Date last updated
7/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double blind, placebo controlled trial of the effectiveness of “post donation” short term iron replacement in female whole blood donors with a daily oral dose of 45 mgs elemental iron
Scientific title
In female whole blood donors aged 18-45 years does 45mg carbonyl iron daily for 56 days reduce the incidence of iron deficiency when compared to a placebo ( no treatment)
Secondary ID [1] 858 0
Australian Red Cross Blood Service (ARCBS) protocol No 2007#9
Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) Scheme Number 2008/224
Universal Trial Number (UTN)
Trial acronym
FIRST = Ferritin II – Iron Replacement Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency in female blood donors aged 18-45 years 4735 0
Condition category
Condition code
Blood 237064 237064 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
45mg carbonyl iron taken orally once daily for 56 days
Intervention code [1] 4509 0
Prevention
Intervention code [2] 236789 0
Treatment: Drugs
Comparator / control treatment
Placebo 625mg caplet containing 273mg lactose taken orally once daily for 56 days.
Control group
Placebo

Outcomes
Primary outcome [1] 5903 0
The change in total body iron (TBI) as determined by ferritin concentration and soluble transferrin receptor concentration in serum from Index donation to Week 12 in donors receiving iron supplementation versus placebo
Timepoint [1] 5903 0
TBI is measured at the time of blood donation and then at 12 weeks after donation to determine total change
Primary outcome [2] 5904 0
Iron deficiency anaemia as determined by changes in haemoglobin in a venous blood sample and total body iron (TBI) as determined by ferritin concentration and soluble transferrin receptor concentration in serum from Index donation to Week 12 in donors receiving iron supplementation versus placebo
Timepoint [2] 5904 0
Haemoglobin(venous) and TBI is measured at the time of blood donation and then at 12 weeks after donation to determine total change
Secondary outcome [1] 241949 0
Eligibility to donate at the Week 12 visit as determined by i) capillary haemoglobin and ii) venous haemoglobin.
Timepoint [1] 241949 0
12 weeks after initial blood donation
Secondary outcome [2] 241950 0
The incidence of gastrointestinal complaints in participants as determined by a self-administered diary, self reported compliance and tablet counts
Timepoint [2] 241950 0
1, 4 8 and 12 weeks after initial blood donation

Eligibility
Key inclusion criteria
To be eligible to participate an individual must:
1. Be a registered female blood donor aged 18-45 years who has donated successfully on at least one occasion in the last 2 years and who is eligible to donate on their first study visit in accordance with “Guidelines for the Selection of Blood Donors” Australian Red Cross Blood Service (ARCBS)Standard Operating Procedure (SOP) (DAP-L2-001);
2. Have a reasonable expectation of adherance to the ARCBS Donor Acceptance Criteria (as per “Guidelines for the Selection of Blood Donors” ARCBS SOP DAP-L2-001) to enable the participant to donate at their 12 week follow-up visit;
3.Be able to provide written informed consent to participate in the trial;
4.Be contactable by phone for the duration of the study period;
5.Not be pregnant or breast feeding;
6.Not be intending to become pregnant in the next 6 months;
7.Agree to use an effective, medically reliable method of preventing conception (such as condoms, the combined oral contraceptive pill, an intrauterine device [IUD], some implants, injectables, sexual abstinence or a vasectomised partner) for the duration of the trial, unless surgically sterile, if the participant is sexually active and of child bearing potential. 8.Be able and willing to comply with the Protocol;
9.Not be travelling outside of Australia during their participation in the trial;
10.Be able to attend the 12-week follow-up visit;
11.Special notes for inclusion
11.1 ARCBS staff members are able to participate if willing and meet the above inclusion criteria;
11.2 Individuals who have had previous deferrals for iron deficiency or iron deficiency anaemia are able to participate if they meet the inclusion criteria
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
An individual is not eligible to participate in this trial if they:
1.Have a 20 g/L decrease in Haemoglobin (Hb) from their previous donation;
2.Are therapeutic donors;
3.Have polycythaemia, haemochromatosis (including those who are homozygous or compound heterozygous as identified by genetic screening and may or may not have developed iron overload), or porphyria cutanea tarda (PCT), or other conditions associated with iron overload or elevated iron levels whether or not the cause is known;
4.Have a family history of haemochromatosis (and have not been tested to exclude genetic predisposition to the condition);
5.Have a current or prior history of conditions affecting the gastrointestinal system including but not limited to: gastric or duodenal ulcers, helicobacter, inflammatory bowel disease, coeliac disease, Crohn’s disease, irritable bowel syndrome, reflux, lactose intolerance, stomas, ileostomy, any gastrointestinal blood loss, bowel cancer, polyps, diverticular disease or constipation requiring regular medication (unless only requiring simple over the counter laxative treatment as recommended by a doctor less than once per month and no history of hospital attendance or admission or causing abdominal pain or needing enemas);
6.Currently having symptoms and/or being investigated for any bowel symptoms;
7.Have liver or pancreatic problems not including diabetes;
8.Have a history of red cell abnormalities including hereditary elliptocytosis, Glucose 6Phosphatase Dehydrogenase (G6PD)deficiency, hereditary spherocytosis or any known form of haemoglobinopathy including all thalassaemia phenotypes and sickle cell trait;
9.Have a history of an inflammatory or autoimmune condition or illness e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE);
10.Have a past history or are currently under treatment for vitamin B12 or folate deficiency or any other non-iron deficiency anaemia;
11.Have a current diagnosis of asthma requiring any form of medication including inhalers in the previous 2 years;
12.Are currently taking iron tablets or vitamin supplements containing a daily equivalent of more than 5 mg elemental iron;
13.Are currently being treated for iron deficiency or iron deficiency anaemia including those currently on a course of iron tablets to replenish stores;
14.Prior to the commencement of the trial are regularly taking aspirin or non sterodial anti-inflammatory drugs (NSAIDs); regularly is defined as taking aspirin or NSAIDs more than once per week;
15.Are currently taking any of the following medications: H2 antagonists (ranitidine, cimetidine, famotidine, nizatidine), proton pump inhibitors (including omeprazole, esomeprazole, lansoprazole), bisphosphonates (alendronate, clodronate, etidronate, ibandronic acid, pamidronate, risedronate, tiludronate, zoledronic acid), levodopa or carbidopa, methyldopa, penicillamine, quinolones (ciprofloxacin, moxifloxacin, norfloxacin, ofloxacin [excluding topical antibiotic preparations]), tetracyclines or thyroid hormones (thyroxin, liothyronine);
16.Are currently taking antacids more than once per month;
17.Are currently taking calcium supplements as an evening dose;
18.Have had episodes of chronic urticaria of unknown cause or any allergic reaction where episodes have been associated with systemic features such as bronchospasm, hypotension, upper airways swelling or anaphylaxis, or where there is the potential for a systemic reaction necessitating carrying an Epipen 'Registered Trademark' or equivalent;
19.Have a history of allergy to a preparation containing iron or those that have had a significant intolerance necessitating medical intervention;
20.Have a known allergy or intolerance to any of the additives within Feosol 'Registered Trademark' including milk, lactose, sorbitol, hypromellose, carnauba wax, crospovidone, Food Drug and Cosmetic (FD&C) Blue#2 Aluminium (AL) Lake, FD&C Red #40 AL Lake, FD&C yellow #6 AL Lake, magnesium stearate, polydextrose, polyethylene glycol 8000, stearic acid, titanium dioxide, triacetin;
21.Have a known allergy or intolerance to any of the additives within the placebo including lactose, microcrystalline cellulose, maize starch, sodium starch glycolate, titanium dioxide, talc, FD&C Red#40, povidone, magnesium stearate;
22.Have a known allergy to aspirin or NSAIDs;
23. Have an allergy which is suspected to be due to a food product, additive or preservative, but has not been identified;
24. Are aware or have an expectation that they will be having surgery or a procedure performed during the trial period e.g. requiring admission to a hospital (including day procedures or minor procedures) and/or anaesthetic required;
25. Are aware or have an expectation that they will be having major dental work or surgery e.g. requiring anaesthetic and/or hospital admission (including day procedures);
26. Have participated in any other clinical trial within 30 days prior to enrolling in this trial or have undertaken or plan to participate in any other trial for 3 months after the study period is completed; or
27. Are deemed by the Investigator to be uncooperative, unable to understand the study requirements or otherwise unsuitable for inclusion into this trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Donors will be screened at interview to ensure suitable for study and consented. They must be eligible to donate whole blood. After consent donor will proceed to give samples for estimation of Hameoglobin,sTfR (soluble transferrin receptor) and serum ferritin levels. Allocation of treatment is by central randomization by computer off site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out by Trident Clinical Research Pty Ltd. The sequence of allocation of carbonyl iron or placebo to donors will be assertained via a computerised randomisation program. Donors will be assigned a numbered packet sequentially on enrolment. The number on the packet will become the trial randomisation number for the participant
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2009
Actual
20/03/2009
Date of last participant enrolment
Anticipated
Actual
20/08/2010
Date of last data collection
Anticipated
Actual
31/12/2010
Sample size
Target
260
Accrual to date
Final
282
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4914 0
Self funded/Unfunded
Name [1] 4914 0
Australian Red Cross Blood Service
Country [1] 4914 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
Level 6 464 St Kilda Rd
Melbourne Vic 3001
Country
Australia
Secondary sponsor category [1] 4443 0
None
Name [1] 4443 0
Address [1] 4443 0
Country [1] 4443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6979 0
ARCBS Ethics Committee
Ethics committee address [1] 6979 0
Level 6 464 St Kilda Rd
Melbourne Vic 3001
Ethics committee country [1] 6979 0
Australia
Date submitted for ethics approval [1] 6979 0
Approval date [1] 6979 0
20/02/2009
Ethics approval number [1] 6979 0
2007#9 Amendment Iron Replacement Study

Summary
Brief summary
The objectives of this trial are to determine whether a post donation 8 week course of 45 mg elemental carbonyl iron in females aged 18 -45:
-is effective in replacing iron lost as a consequence of blood donation,
- improves the donor’s eligibility to donate at their subsequent 3 monthly visit as determined by their capillary haemoglobin level,
and is well tolerated
Trial website
Trial related presentations / publications
Marks DC, Speedy J, Robinson KL, Brama T, Capper HR, Mondy P, et al.
An 8-week course of 45 mg of carbonyl iron daily reduces iron deficiency in female whole blood donors aged 18 to 45 years: results of a prospective randomized controlled trial. Transfusion. 2014;54(3 Pt 2):780-8.
Public notes

Contacts
Principal investigator
Name 29581 0
Dr Dr Anthony Keller
Address 29581 0
c- Dr Joanna Speedy
301 Pirie Street
Adelaide, 5000
Country 29581 0
Australia
Phone 29581 0
61 8 8112 1389
Fax 29581 0
Email 29581 0
[email protected]
Contact person for public queries
Name 12828 0
Dr Joanna Speedy
Address 12828 0
Australian Red Cross Blood Service
301 Pirie Street
Adelaide
Country 12828 0
Australia
Phone 12828 0
61 8 8112 1389
Fax 12828 0
Not applicable
Email 12828 0
[email protected]
Contact person for scientific queries
Name 3756 0
Dr Joanna Speedy
Address 3756 0
Australian Red Cross Blood Service
301 Pirie Street
Adelaide
Country 3756 0
Australia
Phone 3756 0
61 8 8112 1389
Fax 3756 0
not applicable
Email 3756 0
[email protected],au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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